MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number	400SMTSFT0610
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device is implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pca) using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil through a non-penumbra microcatheter and into the target location, however, while advancing the last third of the smart coil into the aneurysm, the smart coil straightened out and would not form loops, causing the microcatheter to back out of the aneurysm.Therefore, the smart coil was removed.The physician then attempted to place a second smart coil, however, the same issue occurred and the last third of the smart coil stiffened up, causing the microcatheter to back out of the aneurysm.With effort, the physician was able to fully advance the smart coil and successfully detached it within the target location.The procedure was then completed using additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6989090
• Report Number: 3005168196-2017-01904
• Device Sequence Number: 1769856
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F68144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1